(a) the conformity of the devices is appropriately checked, in accordance with the quality
management system under which the devices are manufactured, before a device is released;
(b) the technical documentation and the EU declaration of conformity are drawn up and
kept up-to-date;
(c) the post-marketing surveillance obligations shall implement and keep up to date the
post-market surveillance system
(d) the obligation to report serious incidents and field safety corrective actions